Training Features

Good Documentation Practices (GDP/GDocP)

Master Good Documentation Practice (GDP/GDoP) and ensure compliance, accuracy, and audit readiness in every record you handle.
Format

E-Learning

Level

Basic

Trainer

René Schings

Exam

Exam and certificate included

Duration

1 hour and 30 min
7 modules

Price

€ 290 or equivalent currency

Mastering Good Documentation Practice (GDP): Ensuring Quality
and Data Integrity

In the world of regulated industries, documentation is far more than just paperwork—it is an essential component of the product itself. Whether you are involved in pharmaceuticals, medical devices, or clinical research, the quality and reliability of your records are what ultimately guarantee product safety and regulatory compliance.

This comprehensive e-learning program is designed to guide you through the fundamental principles and practical applications of Good Documentation Practice (GDP). Rooted in the core philosophy that “if it isn’t documented, it didn’t happen,” this training will equip you with the tools to ensure your records are always Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+).

Through interactive modules and real-world scenarios, you will learn how to master daily documentation essentials, navigate electronic record requirements, and maintain audit-ready data integrity every single day.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
  • Define the core principles of risk management and its importance in the medical device life cycle. 
  • Identify and explain the requirements of the ISO 14971:2019 standard. 
  • Outline the step-by-step Risk Management Process, from planning to post-production. 
  • Differentiate between key terms such as Harm, Hazard, Hazardous Situation, and Risk. 
  • Apply the hierarchy of risk control measures and understand the concept of overall residual risk. 
  • Participate in a multi-disciplinary risk management team 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 1 hour and 30 minutes
  • Format: Self-paced e-learning including video's, interactive content, and quizzes.
By the end of this course, learners will be able to:
  • Define the core principles of risk management and its importance in the medical device life cycle. 
  • Identify and explain the requirements of the ISO 14971:2019 standard. 
  • Outline the step-by-step Risk Management Process, from planning to post-production. 
  • Differentiate between key terms such as Harm, Hazard, Hazardous Situation, and Risk. 
  • Apply the hierarchy of risk control measures and understand the concept of overall residual risk. 
  • Participate in a multi-disciplinary risk management team 

Comprehensive Regulatory Expertise

Flexible learning designed for busy professionals seeking regulatory expertise.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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